2017-08-11 16:21:45 UTC

FDA Issues Alert for Liquid-Filled Intragastric Balloon Systems

Aug. 11, 2017

Providers encouraged to report all adverse events to the FDA.

The FDA has issued an update to alert health-care providers of five deaths in patients with liquid-filled instagastric balloon systems— devices used to treat obesity. These devices from these deaths included Orbera Intragastric Balloon System, manufactured by Apollo Endo Surgery, and the ReShape Integrated Dual Balloon System, manufactured by ReShape Medical Inc. Death occurred within a month or less of balloon placement. 

While the root cause of death has not been definitively attributed to the devices or insertion procedures, the FDA recommends that providers closely monitor patients with these devices for complications. 

AGA offers obesity resources for you and your patients including information on safe treatment options.

Michael Kochman, MD, AGAF, former chair of the AGA Center for GI Innovation and Technology, has provided more background on what this FDA communication means and how it impacts GI’s. Read his comments and join the discussion in the AGA Community.

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